Nurse Reduction of Pulled Elbow

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Andrew Dixon, University of Alberta
ClinicalTrials.gov Identifier:
NCT00993954
First received: October 8, 2009
Last updated: December 28, 2014
Last verified: December 2014
Results First Received: November 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Radial Head Subluxation
Intervention: Procedure: Reduction of Radial Head Subluxation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 Patients in the physician group were incorrectly reduced by the triage nurse 21 patients in the nurse group either had no study form or the nurse did not attempt reduction

Reporting Groups
  Description
Nurse Reduction

Patients randomized to reduction by nurse.

Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion

Physician Reduction

Patients randomized to treatment by Emergency Department Physician in traditional ED manner

Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion


Participant Flow:   Overall Study
    Nurse Reduction     Physician Reduction  
STARTED     145     123  
COMPLETED     124     121  
NOT COMPLETED     21     2  
Protocol Violation                 21                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nurse Reduction

Patients randomized to reduction by nurse.

Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion

Physician Reduction

Patients randomized to treatment by Emergency Department Physician in traditional ED manner

Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion

Total Total of all reporting groups

Baseline Measures
    Nurse Reduction     Physician Reduction     Total  
Number of Participants  
[units: participants]
  124     121     245  
Age  
[units: Years]
Mean (Standard Deviation)
  2.4  (1.0)     2.2  (1.1)     2.3  (1.1)  
Gender  
[units: participants]
     
Female     80     68     148  
Male     44     53     97  
Region of Enrollment  
[units: participants]
     
Canada     124     121     245  
Time from injury  
[units: Minutes]
Median (Inter-Quartile Range)
  88  
  (45 to 153)  
  103  
  (64 to 199)  
  92  
  (54 to 173)  
Number of patient with injury from pull mechanism  
[units: participants]
  118     92     210  
Number of patients with injury from fall mechanism  
[units: participants]
  5     19     24  
Number of patient with injury from other mechanisms  
[units: participants]
  1     10     11  



  Outcome Measures
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1.  Primary:   Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls   [ Time Frame: 10-15 minutes post reduction attempt ]

2.  Secondary:   Time to Discharge From ED (Minutes)   [ Time Frame: End of enrollment ]

3.  Secondary:   Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture.   [ Time Frame: Every 3 months during enrollment ]

4.  Secondary:   Proportion of Patients With RHS Not Identified by Nurse Pathway.   [ Time Frame: End of enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Andrew Dixon
Organization: University of Alberta
phone: 780-492-3553
e-mail: andrew.dixon@albertahealthservices.ca


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrew Dixon, University of Alberta
ClinicalTrials.gov Identifier: NCT00993954     History of Changes
Other Study ID Numbers: 08/29x
Study First Received: October 8, 2009
Results First Received: November 25, 2014
Last Updated: December 28, 2014
Health Authority: Canada: Ethics Review Committee